Back to resultsThe Effect of Stretching and Relaxation Exercises on Anxiety in Individuals With Fibromyalgia
Primary Purpose
Fibromyalgia
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Cervical Extensor Stretch
Cervical Extensor Stretch
Sponsored by
About this trial
This is an interventional other trial for Fibromyalgia focused on measuring exercise
Eligibility Criteria
Inclusion Criteria Volunteer Being diagnosed with fibromyalgia Exclusion Criteria Known neurological disorder Serious orthopedic disorders that will prevent him from exercising Cognitive impairment Using regular NSAIDs Being malnourished and malnourished
Sites / Locations
- HAZAL genç
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Fibromyalgia individual
Healthy volunteers
Arm Description
Cervical Extensor Stretch, cervical flexor stretch, cervical lateral flexion stretch, thoracic stretch, pectoral stretch, lumbar extensor stretch, posterior capsule stretch, knee flexor stretch, gastro-soleus stretch, quadriceps stretch, cat-camel exercise, shoulder circles, neck flip- tilting the neck to the right and left, relaxation of the abdominal and back muscles, posterior pelvic tilt.
Cervical Extensor Stretch, cervical flexor stretch, cervical lateral flexion stretch, thoracic stretch, pectoral stretch, lumbar extensor stretch, posterior capsule stretch, knee flexor stretch, gastro-soleus stretch, quadriceps stretch, cat-camel exercise, shoulder circles, neck flip- tilting the neck to the right and left, relaxation of the abdominal and back muscles, posterior pelvic tilt.
Outcomes
Primary Outcome Measures
Fibromyalgia Impact Questionnaire
In this scale filled by the patient; Physical function, feeling well, not being able to go to work, difficulty at work, pain, fatigue, morning fatigue, stiffness, anxiety and depression were measured.
With the exception of the well-being trait, low scores indicate recovery or less affliction. Each subheading was asked to be scored between 0-10. Values of 50 points and below were considered as mildly affected, and values above 50 points were considered as severely affected.
The Pittsburg Sleep Quality Index
The Pittsburg Sleep Quality Index is a 19-item self-report scale that assesses sleep quality and impairment over the past month. It consists of 24 questions, 19 questions are self-report questions, 5 questions are questions to be answered by the spouse or roommate. The 18 scored questions of the scale consist of 7 components. Each component is evaluated over 0-3 points. The total score of the 7 components gives the scale total score. The total score ranges from 0 to 21. A total score greater than 5 indicates "poor sleep quality".
Beck Anxiety Scale
It measures the frequency of anxiety symptoms experienced by the individual. It is a Likert-type self-assessment scale consisting of 21 items and scored between 0-3. The individual is asked to mark only one of the "None", "Mild", "Moderate" and "Severe" options for each item. The total score range is between 0-63. The high score total indicates the high level of anxiety experienced by the individual.
Fibromyalgia ACR Criterion assessed by Composite the Widespread Pain Scale and the Symptom Severity Scale
It is obtained by adding the Widespread Pain Scale and the Symptom Severity Scale. The maximum total score here is 19+12=31. Accordingly, scores below a total of 12 do not suggest fibromyalgia. Widespread Pain Scale ≥7 and Symptom Severity Scale ≥5.
Secondary Outcome Measures
Full Information
NCT ID
NCT05835427
First Posted
April 17, 2023
Last Updated
July 26, 2023
Sponsor
Istanbul Medipol University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05835427
Brief Title
The Effect of Stretching and Relaxation Exercises on Anxiety in Individuals With Fibromyalgia
Official Title
The Effect of Stretching and Relaxation Exercises on Anxiety in Individuals With Fibromyalgia
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
June 1, 2023 (Actual)
Study Completion Date
July 26, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Medipol University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Fibromyalgia is a non-articular, chronic rheumatic disease of unknown etiology characterized by widespread musculoskeletal pain, sleep disturbance, fatigue, and the presence of multiple tender points.
Detailed Description
Although the exact etiology cannot be determined in fibromyalgia, it is thought that there are many mechanisms that contribute to the formation of Fibromyalgia. Evidence for some biochemical, neurohormonal, central nervous system, immunological, psychological and environmental factors that may play a role in the disease has been found.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
exercise
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Individuals with fibromyalgia and healthy individuals will be included in the study and the effectiveness of the treatment will be examined. Within the scope of the study, relaxation and stretching exercises will be applied to both groups for eight weeks.
Masking
Investigator
Allocation
Non-Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fibromyalgia individual
Arm Type
Experimental
Arm Description
Cervical Extensor Stretch, cervical flexor stretch, cervical lateral flexion stretch, thoracic stretch, pectoral stretch, lumbar extensor stretch, posterior capsule stretch, knee flexor stretch, gastro-soleus stretch, quadriceps stretch, cat-camel exercise, shoulder circles, neck flip- tilting the neck to the right and left, relaxation of the abdominal and back muscles, posterior pelvic tilt.
Arm Title
Healthy volunteers
Arm Type
Experimental
Arm Description
Cervical Extensor Stretch, cervical flexor stretch, cervical lateral flexion stretch, thoracic stretch, pectoral stretch, lumbar extensor stretch, posterior capsule stretch, knee flexor stretch, gastro-soleus stretch, quadriceps stretch, cat-camel exercise, shoulder circles, neck flip- tilting the neck to the right and left, relaxation of the abdominal and back muscles, posterior pelvic tilt.
Intervention Type
Other
Intervention Name(s)
Cervical Extensor Stretch
Intervention Description
Fibromyalgia individual: Within the scope of the study, relaxation and stretching exercises will be applied to both groups for eight weeks.
Intervention Type
Other
Intervention Name(s)
Cervical Extensor Stretch
Intervention Description
Healthy volunteers : Within the scope of the study, relaxation and stretching exercises will be applied to both groups for eight weeks.
Primary Outcome Measure Information:
Title
Fibromyalgia Impact Questionnaire
Description
In this scale filled by the patient; Physical function, feeling well, not being able to go to work, difficulty at work, pain, fatigue, morning fatigue, stiffness, anxiety and depression were measured.
With the exception of the well-being trait, low scores indicate recovery or less affliction. Each subheading was asked to be scored between 0-10. Values of 50 points and below were considered as mildly affected, and values above 50 points were considered as severely affected.
Time Frame
8 weeks
Title
The Pittsburg Sleep Quality Index
Description
The Pittsburg Sleep Quality Index is a 19-item self-report scale that assesses sleep quality and impairment over the past month. It consists of 24 questions, 19 questions are self-report questions, 5 questions are questions to be answered by the spouse or roommate. The 18 scored questions of the scale consist of 7 components. Each component is evaluated over 0-3 points. The total score of the 7 components gives the scale total score. The total score ranges from 0 to 21. A total score greater than 5 indicates "poor sleep quality".
Time Frame
8 weeks
Title
Beck Anxiety Scale
Description
It measures the frequency of anxiety symptoms experienced by the individual. It is a Likert-type self-assessment scale consisting of 21 items and scored between 0-3. The individual is asked to mark only one of the "None", "Mild", "Moderate" and "Severe" options for each item. The total score range is between 0-63. The high score total indicates the high level of anxiety experienced by the individual.
Time Frame
8 weeks
Title
Fibromyalgia ACR Criterion assessed by Composite the Widespread Pain Scale and the Symptom Severity Scale
Description
It is obtained by adding the Widespread Pain Scale and the Symptom Severity Scale. The maximum total score here is 19+12=31. Accordingly, scores below a total of 12 do not suggest fibromyalgia. Widespread Pain Scale ≥7 and Symptom Severity Scale ≥5.
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria
Volunteer
Being diagnosed with fibromyalgia Exclusion Criteria
Known neurological disorder
Serious orthopedic disorders that will prevent him from exercising
Cognitive impairment
Using regular NSAIDs
Being malnourished and malnourished
Facility Information:
Facility Name
HAZAL genç
City
Istanbul
ZIP/Postal Code
34070
Country
Turkey
12. IPD Sharing Statement
Citations:
PubMed Identifier
34151818
Citation
Yoo SA, Kim CY, Kim HD, Kim SW. Effects of progressive muscle relaxation therapy with home exercise on pain, fatigue, and stress in subjects with fibromyalgia syndrome: A pilot randomized controlled trial. J Back Musculoskelet Rehabil. 2022;35(2):289-299. doi: 10.3233/BMR-191703.
Results Reference
background
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The Effect of Stretching and Relaxation Exercises on Anxiety in Individuals With Fibromyalgia
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